More than a year after a fungal meningitis outbreak began sickening hundreds, killing dozens and causing U.S. lawmakers to rethink how compounding pharmacies are regulated, some victims of the outbreak are still suffering the effects of contaminated epidural steroid injections distributed nationwide.
On October 23, the U.S. Centers for Disease Control and Prevention (CDC) issued a report on the outbreak one year after the drugs believed to have caused it were recalled.
The report was accompanied by two studies published in the New England Medical Journal, including a clinical paper on the early stages of the outbreak, and a final report on efforts to combat its spread and deadly effects.
According to the CDC, there has been only one new reported case of injury linked to epidural steroid injections distributed by the New England Compounding Center (NECC) since July 2013. The outbreak started in the summer of 2012 and included 751 cases of fungal meningitis and other infections in 20 states. The outbreak killed 64 people. Michigan was hit hardest, with 69 cases of meningitis, and most of those cases also involving spinal infections as well. That state recorded 19 deaths.
While the outbreak is considered over, many victims are still suffering from its effects, the CDC reports. In addition to continuing problems caused by the initial infections, which can take months to fight, the powerful antifungal treatments also cause harsh side effects. In addition, most of those who received the tainted injections were already suffering from severe back pain, which the injections were supposed to help alleviate.
The outbreak could have even been worse. At the time of the initial injection recall, the CDC estimated that NECC distributed about 17,000 vials of preservative-free methylprednisolone acetate in three lots that needed to be recalled. But by the time the recall went out, an estimated 13,000 patients had been exposed to the potentially contaminated drugs. The contamination of the vials was so bad that FDA investigators were able to visibly see fungus floating around in sealed vials still waiting at NECC to be shipped out to pain clinics and hospitals nationwide.
“One critical component of the public health response was the rapid, active outreach targeting both patients and clinicians,” CDC researchers wrote. “Anecdotal data collected during the first week of the outbreak indicated that many of the initial patients had mild-to-moderate symptoms that ordinarily would not have prompted urgent medical evaluation.”
Compounding Pharmacy Crackdown
While rapid response quickly began addressing the outbreak, information revealed in the aftermath has suggested that the entire outbreak could have been prevented. Both the FDA and the state of Massachusetts knew there were problems at NECC for years, but took little action. The FDA claimed it was because the agency was uncertain as to its regulatory authority following a number of contradictory verdicts in federal court that appeared to make regulation of compounding pharmacies different from one part of the country to the other.
After the reported infections were linked to NECC epidural steroid injections, the compounding pharmacy’s operations were shut down and the company filed for bankruptcy in the face of numerous fungal meningitis lawsuits.
Stung by the allegations that it failed to do its job, the FDA has initiated a nationwide crackdown on compounding pharmacies over the past year, resulting in numerous recalls and a number of cases where the pharmacies contested the FDA’s right to regulate them.
Compounding pharmacies are traditionally small operations that mix drugs that are unavailable from a large manufacturer for local hospitals on a prescription basis. But over time, some have grown to be de facto drug manufacturers, distributing drugs on a national level that the FDA has never inspected to guarantee they were safe. NECC, for example, sent sales reps around the country and pitched its non-FDA approved injections, which some studies later said do not even effectively alleviate back pain.
The controversy has led to legislation that creates a hybrid tier of compounding manufacturer under FDA regulation, while isolating smaller compounding pharmacies from federal oversight.
“This has been the largest outbreak of healthcare-associated infections ever reported in the United States,” the CDC reports. “Since the outbreak began, additional outbreaks have been identified and linked to contaminated products from other compounding pharmacies. These outbreaks show the urgent need to address shortfalls in the oversight and safety of compounded drugs to reduce the inherent risk associated with these products, which have not undergone review and approval by the Food and Drug Administration.”